A Fully Automated Web-Based Program Improves Lifestyle Habits and HbA1c in Patients With Type 2 Diabetes and Abdominal Obesity: Randomized Trial of Patient E-Coaching Nutritional Support (The ANODE Study)

Journal of Medical Internet Research

Nov 2017

DOI: 10.2196/jmir.7947

Citations:98

Influential Citations:12

Interventional (Human) Studies

COI

Enhanced Details

Methods

Design: 16-week, open-label, randomized, 1:1 parallel-arm trial conducted at two university hospitals in Paris, France. Participants: adults 18-75 years with abdominal obesity and type 2 diabetes (n=120; 60 per arm; 66.7% female).

Results

ANODE improved dietary quality and produced clinically relevant weight loss and glycemic benefits versus usual care over 16 weeks. Diet quality (DQI-I) increased by 4.55 points in the intervention vs -1.68 in control (P<0.01). Weight and waist circumference decreased more with ANODE; HbA1c improved; a higher proportion achieved >3% weight loss (33.3% vs 6.7%) and >5% weight loss (20.0% vs 3.3%). No significant differences in blood pressure, lipids, liver enzymes, fasting glucose, hs-CRP, or VO2 max overall; per-protocol analysis suggested possible VO2 max improvement. Self-reported physical activity did not increase. Satisfaction was high. Conclusion: Fully automated web-based ANODE can be delivered remotely with limited human resources and has potential for cost-effectiveness and broad dissemination if long-term sustainability is demonstrated.

Limitations

Short follow-up (16 weeks); small sample (n=120); open-label design; two recruitment centers; lack of objective trackers for physical activity.

Abstract

Background The prevalence of abdominal obesity and type 2 diabetes mellitus (T2DM) is a public health challenge. New solutions need to be developed to help patients implement lifestyle changes. Objective The objective of the study was to evaluate a fully automated Web-based intervention designed to help users improve their dietary habits and increase their physical activity. Methods The Accompagnement Nutritionnel de l’Obésité et du Diabète par E-coaching (ANODE) study was a 16-week, 1:1 parallel-arm, open-label randomized clinical trial. Patients with T2DM and abdominal obesity (n=120, aged 18-75 years) were recruited. Patients in the intervention arm (n=60) had access to a fully automated program (ANODE) to improve their lifestyle. Patients were asked to log on at least once per week. Human contact was limited to hotline support in cases of technical issues. The dietetic tool provided personalized menus and a shopping list for the day or the week. Stepwise physical activity was prescribed. The control arm (n=60) received general nutritional advice. The primary outcome was the change of the dietary score (International Diet Quality Index; DQI-I) between baseline and the end of the study. Secondary endpoints included changes in body weight, waist circumference, hemoglobin A1c (HbA1c) and measured maximum oxygen consumption (VO2 max). Results The mean age of the participants was 57 years (standard deviation [SD] 9), mean body mass index was 33 kg/m² (SD 4), mean HbA1c was 7.2% (SD 1.1), and 66.7% (80/120) of participants were women. Using an intention-to-treat analysis, the DQI-I score (54.0, SD 5.7 in the ANODE arm; 52.8, SD 6.2 in the control arm; P=.28) increased significantly in the ANODE arm compared to the control arm (+4.55, SD 5.91 vs -1.68, SD 5.18; between arms P<.001). Body weight, waist circumference, and HbA1c changes improved significantly in the intervention. Conclusions Among patients with T2DM and abdominal obesity, the use of a fully automated Web-based program resulted in a significant improvement in dietary habits and favorable clinical and laboratory changes. The sustainability of these effects remains to be determined. Trial Registration ClinicalTrials.gov NCT02343107; http://clinicaltrials.gov/ct2/show/NCT02343107 (Archived by WebCite at http://www.webcitation.org/6uVMKPRzs) show less